Manas Dasgupta
NEW DELHI, May 27: Initiating a major course correction to expedite imports of foreign-made Corona vaccines, the centre is learnt to have scrapped the condition of “local trials” for “well established” vaccines accepted in some foreign countries to fast-track imports.
The condition of satisfactory local trials before approval for emergency use in India along with their demand for indemnity against any compensation for side-effects had been holding back the vaccine manufacturers in other countries including the US pharma major Pfizer from agreeing to supply vaccines to India. The foreign companies have already refused to deal with state governments for contracts for vaccine supply and had made it clear that they would sign agreements only with the centre if these two conditions were fulfilled.
The “local trial” provision was scrapped after the government made some headway in talks with Pfizer for “earliest possible” import of its vaccines. The government was also in talks with Johnson & Johnson and Moderna for the import of their vaccines. “We reiterate our request to all international vaccine makers to come and make in India – for India and for the world,” the government said.
Pfizer has reportedly told the government that its vaccine has shown “high effectiveness” against the mutant strain dominant in India and on people of Indian ethnicity or nationality. The company has also said its shots are suitable for all above 12 years and can be stored for a month at 2-8 degrees.
The US-based vaccine maker has said it is ready to offer 5 crore doses to India between July and October this year, but has sought relaxations including indemnity in a series of recent interactions with the government, according to Press Trust of India.
Pfizer has immunity in countries like the US where it cannot be sued for any adverse effects. India has so far not given any manufacturer indemnity against the costs of compensation for any severe side effects.
“The current situation in India, and across the world, is not ‘business as usual’ and we must not respond to it with processes as usual too,” Pfizer told the government, media reports said. Report said after the government’s meetings with Pfizer CEO Albert Bourla, it was agreed that both sides would jointly work on three key factors to speed up approval — procurement through a central government pathway; indemnity and liability; and doing away with post-approval bridging studies.
“As soon as Pfizer indicated vaccine availability, the central government and the company have been working together for the earliest possible import of the vaccine,” said VK Paul, the head of India’s Covid task force.
With only two local vaccines currently being used, “Covishield” being manufactured by the Pune-based Serum Institute of India, and “Covaxin” manufactured by Hyderabad-based Bharat Biotech, India since January 16 when the vaccination drive was launched in the country has so far vaccinated about 20 crore people including only about four crore of the 130 crore odd population, just about three per cent of the total population, vaccinated fully with two doses. India has just added Russia-made Sputnik V in its basket of vaccines but it will take several months before its production and supply could be stepped up.
Besides the production shortage in the two Indian vaccine manufacturing companies, which together presently has the capacity to produce little over 27 lakh doses per day of which only 57 per cent reaching the Indian population, the country would take more than a year to complete the vaccination. With the government insisting that vaccination was the best way to fight against the “once in a lifetime pandemic” as stated by the prime minister Narendra Modi, import of foreign-made vaccine in large quantity would be necessary to expedite the vaccination process.
Last month, India pledged to fast-track approvals for foreign vaccines but its insistence on local trials was a key reason for stalled discussions with Pfizer.
“The provision has now been further amended to waive the trial requirement altogether for the well-established vaccines manufactured in other countries,” official sources said on Thursday. This was earlier announced by Niti Aayog (health) member V K Paul who said the vaccine approved by the US Food and Drug Administration, European Medicines Agency and other reputed bodies, will not be required to undergo prior bridging trial and trials for “well-established” vaccines have been waived altogether.
Many state governments have flagged the vaccine shortage problem to the Centre, with chief ministers claiming the Centre was not doing enough to procure vaccines from abroad.
The government countered the allegation, calling it a myth. Dr Paul said on Thursday said the government was engaged in discussions and deliberations with many pharmaceutical giants. The government even offered assistance for the domestic production of their vaccines. However, vaccines being in “limited supply globally” has hampered their efforts, Dr Paul said in a statement.
The decision to scrap local trial was taken even as the country reported 211,298 new cases on Thursday, marginally higher than Wednesday’s 2.02 lakh infections but nearly half the daily infections it recorded earlier this month, which pushed the overall caseload to 27.37 million.
Paul, however, blamed the states for the current vaccine fiasco claiming that some of the states had coerced the Centre into expanding the availability of vaccines despite being aware of being inadequately prepared.
Dr. Paul, Chairman, National Empowered Group on Vaccine Administration, said vaccine supply, which was managed by the Centre from January-April, was “well administered” but wasn’t upto the mark in May.
The Centre did all the “heavy-lifting”, which included funding vaccine manufacturers, accelerating approvals, ramping up production and bringing foreign vaccines to India. “The vaccine procured by the Centre is supplied wholly to the States for free administration to people. All this is very much in the knowledge of the States. The Government of India has merely enabled the States to try procuring vaccines on their own, on their explicit requests. The States very well knew the production capacity in the country and what the difficulties are in procuring vaccines directly from abroad,” said his note, which was released by the centre’s Press Information Bureau in the form of a ‘Myths Vs Facts’ questionnaire.
“States, who had not even achieved good coverage of healthcare workers and frontline workers in three months wanted to open up the process of vaccination and wanted more decentralisation. Health is a state subject & the liberalised vaccine policy was a result of the incessant requests being made by the States to give states more power. The fact that global tenders have not given any results only reaffirm what we have been telling the States from day one: that vaccines are in short supply in the world and it is not easy to procure them at short notice,” the note said.
Dr. Paul said the country would produce 10 crore doses of Covaxin by October. The earlier estimate was that these production numbers would be reached by September, according to a note from the Department of Biotechnology in mid-April.
The SII was ramping up Covishield production of 6.5 crore doses a month to 11.0 crore doses, Dr. Paul said.
Trials in children would begin soon, he said. “However, vaccinating children should not be decided on the basis of panic in WhatsApp groups and because some politicians want to play politics. It has to be a decision taken by our scientists after adequate data is available based on trials,” he said.